Nemes Laszlo
SELLAS Life Sciences (NASDAQ:SLS) traded higher in the premarket on Tuesday after the New York-based biotech said that a Phase 2 trial that tested its antitumor agent SLS009 (tambiciclib) as part of a combination regimen for acute myeloid leukemia met all the endpoints.
The open-label trial, which had enrolled 54 patients with relapsed/refractory acute myeloid leukemia (r/r AML), exceeded the target overall response rate (ORR) of 20%, meeting the study’s main goal, according to the company.
The single-arm trial tested SLS009 with chemotherapy, azacitidine, and the leukemia drug venetoclax, marketed by AbbVie (ABBV) and Roche (OTCQX:RHHBF) (OTCQX:RHHBY) as Venclexta, in two dose levels.
The drug combination was well tolerated by patients, SELLAS (NASDAQ:SLS) said, adding that there were no dose-limiting toxicities and the addition of SLS009 to venetoclax/azacitidine didn’t increase toxicities.
The company intends to advance SLS009 in a randomized trial that is expected to begin enrollments in Q1 2026. The study, designed to include newly diagnosed AML patients as well as those resistant to venetoclax/azacitidine, is expected to support a New Drug Application (NDA) filing with the FDA.